A randomized trial of a composite T2-biomarker strategy adjusting corticosteroid treatment in severe asthma: a post hoc analysis by sex.
Eastwood, Matthew C Busby, John Jackson, David J Pavord, Ian D Hanratty, Catherine E Djukanovic, Ratko Woodcock, Ashley Walker, Samantha Hardman, Timothy C Arron, Joseph R
Eastwood, Matthew C
Busby, John
Jackson, David J
Pavord, Ian D
Hanratty, Catherine E
Djukanovic, Ratko
Woodcock, Ashley
Walker, Samantha
Hardman, Timothy C
Arron, Joseph R
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2023-01-05
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Abstract
Background: Approximately 5% to 10% of patients with asthma have severe disease, with a consistent preponderance in females. Current asthma guidelines recommend stepwise treatment to achieve symptom control with no differential treatment considerations for either sex.
Objective: To examine whether patient sex affects outcomes when using a composite T2-biomarker score to adjust corticosteroid (CS) treatment in patients with severe asthma compared with standard care.
Methods: This is a post hoc analysis, stratifying patient outcomes by sex, of a 48-week, multicenter, randomized controlled clinical trial comparing a biomarker-defined treatment algorithm with standard care. The primary outcome was the proportion of patients with a reduction in CS treatment (inhaled and oral corticosteroids). Secondary outcomes included exacerbation rates, hospital admissions, and lung function.
Results: Of the 301 patients randomized, 194 (64.5%) were females and 107 (35.5%) were males. The biomarker algorithm led to a greater proportion of females being on a lower CS dose versus standard care, which was not seen in males (effect estimate: females, 3.57; 95% CI, 1.14-11.18 vs males, 0.54; 95% CI, 0.16-1.80). In T2-biomarker-low females, reducing CS dose was not associated with increased exacerbations. Females scored higher in all domains of the 7-item Asthma Control Questionnaire, apart from FEV1, but with no difference when adjusted for body mass index/anxiety and/or depression. Dissociation between symptoms and T2 biomarkers were noted in both sexes, with a higher proportion of females being symptom high/T2-biomarker low (22.8% vs 15.6%; P = .0002), whereas males were symptom low/T2-biomarker high (22.3% vs 11.4%; P < .0001).
Conclusions: This exploratory post hoc analysis identified that females achieved a greater benefit from biomarker-directed CS optimization versus symptom-directed treatment.
Citation
Eastwood MC, Busby J, Jackson DJ, Pavord ID, Hanratty CE, Djukanovic R, Woodcock A, Walker S, Hardman TC, Arron JR, Choy DF, Bradding P, Brightling CE, Chaudhuri R, Cowan D, Mansur AH, Fowler SJ, Howarth P, Lordan J, Menzies-Gow A, Harrison T, Robinson DS, Holweg CTJ, Matthews JG, Heaney LG; Refractory Asthma Stratification Programme (UK) Investigators. A Randomized Trial of a Composite T2-Biomarker Strategy Adjusting Corticosteroid Treatment in Severe Asthma: A Post Hoc Analysis by Sex. J Allergy Clin Immunol Pract. 2023 Apr;11(4):1233-1242.e5. doi: 10.1016/j.jaip.2022.12.019. Epub 2023 Jan 5.
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